Unilateral condylar mandibular fractures: Conservative treatment vs. open reduction and internal fixation. A multi-centre prospective study

Unilateral condylar mandibular fractures: Conservative treatment vs. open reduction and internal fixation. A multi-centre prospective study - COLLUM-study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON45588

Enrollment

Registered

2017-04-12

Start date

2017-07-03

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

condylar neck or base fracture of the mandible fracture of the mandible

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 18 years or older. - Unilateral condylar mandibular fracture (neck and/or base), with or without other fractures of the mandible, with or without injury of the front teeth, caused by trauma. - Dislocation of this fracture, with or without bone contact, on CT-scan. - With dysocclusion.

Exclusion criteria

Exclusion criteria: - No informed consent. - Not able to undergo surgery because of comorbidity. - Not able to understand the Dutch language. - Legally incapable - Mid-face fractures, except unilateral fractures of the zygoma. - Pregnancy

Design outcomes

Primary

Measure	Time frame
The main study parameters are: VAS-score in millimetres, Mixing ability test in pixels, Clinical examination of the mandible (laterotrusion, protrusion, maximal opening of the mouth -interincisal distance-, deviation of the chin when opening) in millimetres, outcome of the SF-36 questionnaire (continuous), outcome of the MFIQ questionnaire (continuous).	—

Secondary

Measure	Time frame
1. Anatomic parameters: - Anatomic position of the fracture on radiologic imaging by means of comparison after mirroring of the contralateral side in millimetres (continuous) and degrees (continuous). - Occlusion disorder (yes/no). Contact of fracture ends (yes/no). 2. Patient characteristics: - Age (continuous) - Sex (male/female) - Trauma mechanism, multiple choice: road traffic accident, violence, falling, sporting injury, other. - Other mandibular fractures, multiple choice: none, coronoid, ramus, angle, body, symphysis, other. - Unilateral zygoma fracture: Yes (ipsi- or contralateral side) / No - Other injuries, multiple choice: neurotrauma, spinal, thoraco-abdominal, extremities, other. - Injury of the teeth: number of injured teeth (continuous) - Pain medication, multiple choice: none, paracetamol, NSAIDs, opioid, other 3. Alteration of treatment (escape treatment) required? (yes/no) a. In case of escape treatment: IMF, operative intra-oral, operative extra-oral, other 4. Co-intervention required? (yes/no) a. In case of co-intervention: IMF with steel wire, IMF with guiding elastics, other 5. (Post)operative complications, multiple choice: none, postoperative bleeding, redo surgery, redo placement of bone screws, swelling, wound infection, infection of osteosynthesis material, wound dehiscence, facial nerve damage, sialocele, (hypertrophic) scarring, parotic fistula, other. 6. Timing of intervention, multiple choice: 1day,2days, 3days, 4days, 5days, 6days, 7days, >7days. 7. Duration of surgery/conservative treatment (continuous). 8. Cost of treatment (continuous). 9. Length of hospitalization (continuous).	—

Measure

Time frame

1. Anatomic parameters: - Anatomic position of the fracture on radiologic imaging by means of comparison after mirroring of the contralateral side in millimetres (continuous) and degrees (continuous). - Occlusion disorder (yes/no). Contact of fracture ends (yes/no). 2. Patient characteristics: - Age (continuous) - Sex (male/female) - Trauma mechanism, multiple choice: road traffic accident, violence, falling, sporting injury, other. - Other mandibular fractures, multiple choice: none, coronoid, ramus, angle, body, symphysis, other. - Unilateral zygoma fracture: Yes (ipsi- or contralateral side) / No - Other injuries, multiple choice: neurotrauma, spinal, thoraco-abdominal, extremities, other. - Injury of the teeth: number of injured teeth (continuous) - Pain medication, multiple choice: none, paracetamol, NSAIDs, opioid, other 3. Alteration of treatment (escape treatment) required? (yes/no) a. In case of escape treatment: IMF, operative intra-oral, operative extra-oral, other 4. Co-intervention required? (yes/no) a. In case of co-intervention: IMF with steel wire, IMF with guiding elastics, other 5. (Post)operative complications, multiple choice: none, postoperative bleeding, redo surgery, redo placement of bone screws, swelling, wound infection, infection of osteosynthesis material, wound dehiscence, facial nerve damage, sialocele, (hypertrophic) scarring, parotic fistula, other. 6. Timing of intervention, multiple choice: 1day,2days, 3days, 4days, 5days, 6days, 7days, >7days. 7. Duration of surgery/conservative treatment (continuous). 8. Cost of treatment (continuous). 9. Length of hospitalization (continuous).

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Countries

Netherlands

Outcome results